Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) are aimed at ensuring that safe and performant medical devices are being placed on the EU market whilst supporting innovation.
These regulations contain important improvements among which stricter control for high-risk devices via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence and increased transparency. To this end, they require the establishment of scientific bodies, namely expert panels, expert laboratories and EU Reference Laboratories (EURLs). Their roles, described in Article 106 of the MDR and Article 100 of the IVDR, are to provide the European Commission, Member States, notified bodies and manufactures with scientific and technical advice, contribute to guidance and other relevant documents, and to identify emerging issues of concern regarding medical devices and in vitro diagnostic medical devices.
The first scientific body to be put in place are the expert panels; EURLs and expert laboratories will be established at a later stage.
What are expert panels in the field of medical devices and IVDs?
Articles 106 and 48(6) of the Medical Device Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR) respectively require the European Commission to create expert panels to support the scientific assessment and advice in the field of medical devices and in vitro diagnostic medical devices.
Expert panels have been designated by means of the Commission Implementing Decision (EU) 2019/1396 in relevant medical fields.
The expert panels have the following tasks, depending on needs
- providing an opinion on the notified bodies’ assessments of clinical evaluation of certain high-risk medical devices and the performance evaluation of certain in vitro diagnostic medical devices
- providing advice to the Medical Device Coordination Group (MDCG) and the European Commission concerning safety and performance of medical devices and in vitro diagnostic medical devices
- providing advice to manufacturers on their clinical development strategy and proposals for clinical investigations
- providing advice to EU countries, manufacturers and notified bodies on various scientific and technical matters
- contributing to the development and maintenance of relevant guidance documents, common specifications and international standards
- providing opinions in response to consultations from manufacturers, EU countries and notified bodies
Who are the experts?
Panel members are top-notch experts in their own field appointed by the European Commission on the basis of their scientific, clinical and technical expertise following a call for expression of interests. The selection is made by the European Commission and the appointment in consultation with the MDCG.
The experts must have
- full rights as a citizen of a Member State of the EU, EFTA or Turkey
- a university degree in a relevant medical or scientific areas
- at least 10 years of relevant professional experience
- good knowledge of the English language allowing active participation in the work of the panels
No financial interest or other interest, which could affect their independence, impartiality and objectivity.
What panels are there?
Experts are appointed for a term of three years, with the possibility of renewal. During this time, they are part of one of the following 12 panels, as listed below
- Screening panel - determines whether there is a need for a scientific opinion
- Orthopaedics, traumatology, rehabilitation, rheumatology
- Circulatory system
- Respiratory system, anaesthesiology, intensive care
- Endocrinology and diabetes
- General and plastic surgery and dentistry
- Obstetrics and gynaecology, including reproductive medicine
- Gastroenterology and hepatology
- Nephrology and urology
- In vitro diagnostic medical devices
The European Commission provides a Secretariat for the expert panels to support the efficient functioning of the expert panels. Its task includes the identification and management of potential conflicts of interests, the supervision of the work, the monitoring of compliance with the rules of procedure, and the publication of opinions, views and positions.
Annual overview of devices subject to Clinical Evaluation Consultation Procedure (CECP)
According to Article 54(4) of Regulation (EU) 2017/745 the Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X and shall submit this overview to the European Parliament, to the Council and to the MDCG.